CEREZYME Drug Profile

Summary for Tradename: CEREZYME

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for CEREZYME
Recent Clinical Trials:	See clinical trials for CEREZYME
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CEREZYME

See drug prices for CEREZYME

Recent Clinical Trials for CEREZYME

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Genzyme, a Sanofi Company	Phase 3
ISU Abxis Co., Ltd.	Phase 1
National Taiwan University Hospital	N/A

See all CEREZYME clinical trials

Recent Litigation for CEREZYME

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Juul Labs Inc v. EZfumes	2020-07-10
MiMedx Group, Inc. v. Tissue Transplant Technology, Ltd.	2014-05-16

See all CEREZYME litigation

Pharmacology for CEREZYME

Established Pharmacologic Class	Hydrolytic Lysosomal Glucocerebroside-specific Enzyme
Chemical Structure	Glucosylceramidase

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for CEREZYME Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for CEREZYME Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	5,236,838	2010-08-17	Company disclosures
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	5,549,892	2013-08-27	Company disclosures

3) Low Certainty: US Patents for CEREZYME Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	10,016,338	2033-03-11	Patent claims search
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	10,028,922	2027-09-17	Patent claims search
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	10,035,766	2029-10-19	Patent claims search
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	10,543,204	2028-06-26	Patent claims search
Genzyme Corporation	CEREZYME	imiglucerase	For Injection	020367	10,577,154	2029-05-13	Patent claims search

International Patents for CEREZYME

Country	Patent Number	Estimated Expiration
Japan	H03503721
World Intellectual Property Organization (WIPO)	9007573
Canada	2006709
Japan	H03502289
Spain	2093642

CEREZYME Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: Cerezyme

Introduction

Cerezyme, a biologic drug developed by Sanofi Genzyme, is used for the treatment of Gaucher's disease, a rare genetic disorder. Here, we will delve into the market dynamics and financial trajectory of Cerezyme, highlighting its performance, market trends, and future outlook.

What is Cerezyme?

Cerezyme is an enzyme replacement therapy (ERT) designed to treat Gaucher's disease, a condition characterized by the deficiency of the enzyme glucocerebrosidase. This deficiency leads to the accumulation of harmful substances in various organs, particularly the spleen, liver, and bones.

Market Landscape

The global Gaucher disease drugs market is expected to grow, with enzyme replacement therapy being the dominant treatment approach. However, there is a shift towards substrate replacement therapy, which is anticipated to register a significant CAGR during the forecast period[4].

Key Players

Sanofi Genzyme is a leading player in the Gaucher disease treatment market, with Cerezyme being one of its flagship products. Other prominent companies in this market include Shire, Pfizer, and Johnson & Johnson[4].

Financial Performance of Cerezyme

Recent Sales Figures

In the fourth quarter of 2023, Cerezyme sales were up 7.4% to €209 million, driven by growth in high inflationary countries such as Argentina and Turkey in the Rest of the World region[1].

Yearly Performance

For the full year 2023, Cerezyme sales increased by 9.1% to €687 million. This growth is part of a broader trend where Cerezyme has consistently shown strong performance in the Rest of the World region[1].

Historical Context

In 2021, Cerezyme sales increased by 13.1% to €181 million in the fourth quarter, reflecting strong growth in the Rest of the World region. This trend has continued, with Cerezyme maintaining its position as a key product in Sanofi's Specialty Care portfolio[5].

Geographic Performance

Rest of the World

Cerezyme has seen significant growth in the Rest of the World region, particularly in countries with high inflation rates such as Argentina and Turkey. This region has been a key driver of Cerezyme's sales growth in recent years[1][5].

Europe and the United States

While the Rest of the World region has been a strong performer, Cerezyme also maintains a presence in Europe and the United States. However, the growth in these regions has been more modest compared to the Rest of the World[1].

Market Trends and Drivers

Enzyme Replacement Therapy

Cerezyme's success is largely due to its position as a leading enzyme replacement therapy for Gaucher's disease. This treatment approach has dominated the market, although there is an emerging trend towards substrate replacement therapy[4].

Patient Base and Accessibility

The U.S. market, in particular, has been significant for Cerezyme due to a widening patient base and easy accessibility to treatments. This has contributed to the drug's strong sales performance in this region[4].

Challenges and Competition

Generic Competition

While Cerezyme remains a market leader, the broader pharmaceutical landscape is subject to generic competition. Other Sanofi products, such as Aubagio, have faced significant declines due to generic competition, although Cerezyme has been less affected by this trend[1].

Emerging Therapies

The shift towards substrate replacement therapy and other emerging treatments could potentially impact Cerezyme's market share in the future. However, as of now, Cerezyme remains a cornerstone in the treatment of Gaucher's disease[4].

Future Outlook

Continued Growth

Sanofi's commitment to investing in R&D and its focus on innovative medicines are expected to support the continued growth of Cerezyme. The drug's approval and strong performance in various regions indicate a positive outlook for the future[1][3].

Market Expansion

With the growing awareness and diagnosis of Gaucher's disease, especially in emerging markets, Cerezyme is poised to benefit from an expanding patient base. This, combined with its established position in the market, suggests sustained growth potential[4].

Conclusion

Cerezyme has demonstrated robust financial performance and market resilience, driven by its strong position in the treatment of Gaucher's disease. As the market continues to evolve with new therapies and treatments, Cerezyme remains a key product in Sanofi's portfolio, with a promising future outlook.

Key Takeaways

• Strong Sales Growth: Cerezyme has shown consistent sales growth, particularly in the Rest of the World region.
• Market Leadership: It remains a leading enzyme replacement therapy for Gaucher's disease.
• Geographic Performance: Strong performance in high inflationary countries and the U.S. market.
• Emerging Trends: Shift towards substrate replacement therapy, but Cerezyme's dominance is expected to continue.
• Future Outlook: Positive due to Sanofi's R&D investments and expanding patient base.

FAQs

What is Cerezyme used for?

Cerezyme is used for the treatment of Gaucher's disease, a rare genetic disorder characterized by the deficiency of the enzyme glucocerebrosidase.

How has Cerezyme performed in recent years?

Cerezyme has shown strong sales growth, with a 7.4% increase in the fourth quarter of 2023 and a 9.1% increase for the full year 2023.

What are the key drivers of Cerezyme's sales growth?

The key drivers include growth in high inflationary countries, an expanding patient base, and easy accessibility to treatments, particularly in the U.S.

Is Cerezyme facing any competition?

While Cerezyme faces some competition from emerging therapies, it remains a market leader in enzyme replacement therapy for Gaucher's disease.

What is the future outlook for Cerezyme?

The future outlook is positive, driven by Sanofi's commitment to R&D, an expanding patient base, and its established market position.

How does Cerezyme compare to other treatments for Gaucher's disease?

Cerezyme is currently the dominant enzyme replacement therapy, although there is a growing trend towards substrate replacement therapy. However, it remains a cornerstone in the treatment of Gaucher's disease.

Sources

1. Sanofi Press Release Q4 2023: "Press Release Q4 2023 English - Sanofi"
2. Biospace: "Sanofi : Strong Q3 performance drives guidance upgrade to around 14% business EPS growth at CER"
3. Sanofi Press Release Q3 2024: "Press release Q3 2024 English - Sanofi"
4. Grand View Research: "Gaucher Disease Drugs Market Size Worth $1.71 Billion by 2025"
5. Sanofi Press Release 2022: "Press Release: Strong 2021 sales and business EPS growth"